康希诺生物股份公司（以下简称"公司"）于近日收到国家药品监督管理局 核准签发的关于重组三价脊髓灰质炎疫苗（Sf-RVN细胞）（以下简称"重组脊 髓灰质炎疫苗"）的《药物临床试验批准通知书》。具体情况如下： 证券代码：688185 证券简称：康希诺 公告编号：2025-018 康希诺生物股份公司 关于重组三价脊髓灰质炎疫苗（Sf-RVN细胞）获得 药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、通知书基本情况 产品名称：重组三价脊髓灰质炎疫苗（Sf-RVN 细胞） 注册分类：预防用生物制品 1.2 类 申请事项：境内生产药品注册临床试验 申请人：康希诺生物股份公司、康希诺（上海）生物科技有限公司 通知书编号：2025LP01807 审批结论：根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理 法》及有关规定，经审查，重组脊髓灰质炎疫苗符合药品注册的有关要求，同意 开展预防由脊髓灰质炎 I 型、II 型和 III 型病毒感染导致的脊髓灰质炎的临床试 验。 二、产品相关情况 公司的重组脊髓 ...

Core Viewpoint - CanSino Biologics has received approval from the National Medical Products Administration for the clinical trial of its trivalent inactivated poliovirus vaccine (Sf-RVN cells), indicating progress in vaccine development and potential market entry [1] Group 1: Company Developments - CanSino Biologics announced the receipt of the clinical trial approval notice for its trivalent inactivated poliovirus vaccine [1] - The vaccine is developed using protein structure design and VLP assembly technology, ensuring it does not contain viral genetic material, which contributes to its safety and immunogenicity [1] - The vaccine is currently undergoing Phase I/II clinical trials in Indonesia [1] Group 2: Regulatory and Clinical Trial Information - The approval from the National Medical Products Administration allows CanSino to proceed with clinical trials in accordance with national drug registration regulations and requirements [1]

Core Viewpoint - The A-share rare earth permanent magnet sector experienced a decline at the beginning of trading, with Huaxin Environmental Protection falling over 7%, and other companies such as Jingyuntong, Wolong New Energy, Ningbo Yunsheng, and Jintian Co., Ltd. also experiencing declines [1] Group 1 - The A-share market for rare earth permanent magnets is showing signs of a downturn [1] - Huaxin Environmental Protection's stock dropped more than 7% [1] - Other companies in the sector, including Jingyuntong, Wolong New Energy, Ningbo Yunsheng, and Jintian Co., Ltd., followed suit with declines [1]

Group 1 - The A-share rare earth permanent magnet sector is experiencing active bidding, with companies such as Wolong New Energy and Jingyuntong hitting the daily limit up [1] - Other companies like Sanchuan Wisdom, Huahong Technology, Baogang Co., and Jintian Co. also opened high, rising over 5% [1]

Group 1 - The core viewpoint highlights the significant growth and performance of the Kexin Pharmaceutical ETF managed by Jiashi, with a notable increase in trading volume and fund size [2] - As of July 9, the Kexin Pharmaceutical ETF achieved a daily average trading volume of 34.95 million yuan over the past month, ranking first among comparable funds [2] - The fund's size increased by 16.76 million yuan in the past two weeks, also ranking first among comparable funds [2] - The ETF saw a total inflow of 12.84 million yuan over the last ten trading days, indicating strong investor interest [2] - The net value of the Kexin Pharmaceutical ETF rose by 36.83% over the past year, showcasing its strong performance [2] Group 2 - The top ten weighted stocks in the Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index account for 50.3% of the index, with leading companies including United Imaging Healthcare and BeiGene [2][4] - On July 9, Shanghai Pharmaceuticals announced an expected net profit of 4.45 billion yuan for the first half of 2025, representing a year-on-year increase of approximately 52% [4] Group 3 - Short-term market expectations for overseas transactions in innovative drugs are high, leading to a continuous rise in valuations [5] - China's innovative drug research and development capabilities are competitive globally, and the trend of innovative drugs going overseas is expected to persist [5] - The commercial health insurance sector in China is anticipated to see significant growth in premium income and payout rates, becoming an important source of funding for innovative drugs [5]

Core Viewpoint - 康希诺 is actively advancing its vaccine development pipeline, focusing on innovative products and expanding its market presence both domestically and internationally [1][2][3] Group 1: Vaccine Development and Commercialization - 康希诺's 13-valent pneumonia conjugate vaccine PCV13i has significant advantages in product characteristics and production processes, showing excellent clinical results and safety profiles [3][4] - The company is targeting the commercialization of PCV13i, which overlaps with its existing product MCV4, enhancing marketing efficiency [4] - The four-valent meningococcal conjugate vaccine MCV4 has received acceptance for age expansion applications for 4-6 years and plans to submit for 18-59 years within the year [5] Group 2: Research and Development Progress - 康希诺 has established five major R&D platforms, with multiple products at various stages of development, including Tdcp for adolescents and adults, which has completed Phase III clinical trials [2][7] - The company is exploring therapeutic vaccine development and has a positive attitude towards expanding into innovative fields [8] - The infant DTcP vaccine's application for market approval has been accepted and is undergoing priority review, with plans for clinical trials for a combination vaccine [6][9] Group 3: Financial Position and Future Plans - As of March 2025, 康希诺 has approximately 34 billion RMB in funds, sufficient for current development needs, with no large-scale investment plans outside of its vaccine industrial park project [2][10] - Future financing plans will be considered based on market conditions and company development stages, with timely announcements to be made if necessary [10]

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 2025年6月30日 | | --- | | 狀態: | | 截至月份: 新提交 | 致：香港交易及結算所有限公司 公司名稱: 康希諾生物股份公司 呈交日期: 2025年7月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06185 | 說明 | H 股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 132,670,900 | RMB | | 1 | RMB | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | | | | RMB | | 0 | | 本月底結存 | | | 132,670,900 | RMB | | 1 | RMB | | 1 ...

Core Viewpoint - The Chinese vaccine industry is transitioning from scale expansion to value creation, driven by national immunization strategies and WHO vaccine prioritization policies, with local companies leveraging technological innovation to enhance multi-valent vaccines and lifecycle protection strategies [1] Group 1: Product Development and Innovation - CanSino Biologics' 13-valent pneumonia vaccine PCV13i has been approved for market launch, representing a significant step in the globalization of domestic vaccines [2] - The core value of PCV13i is based on three pillars: technological breakthroughs, clinical validation, and application optimization [2] - The vaccine employs a unique dual carrier technology using a non-toxic mutant of diphtheria toxin (CRM197) and tetanus toxin (TT), enhancing immunogenicity and reducing interference with other vaccines [3] Group 2: Clinical Data and Efficacy - Clinical data shows that PCV13i significantly outperforms control groups in inducing high levels of specific antibodies against key serotypes that are prevalent in China, confirming its regional adaptability [4] - The safety profile of PCV13i is comparable to that of control vaccines, with adverse reactions primarily being mild, facilitating its commercial application [4] Group 3: Market Demand and Commercialization - The urgency for pneumonia vaccines is underscored by the high mortality rates associated with pneumonia in children under five, particularly in China, where vaccination rates are below 18% [6][8] - The global market for pneumonia vaccines is robust, with the 13-valent pneumonia vaccine consistently ranking among the top-selling vaccines, indicating significant market potential [9] Group 4: Strategic Market Positioning - PCV13i is positioned to leverage existing distribution networks and cold chain logistics established by CanSino's previous vaccine, enhancing market penetration efficiency [10] - The vaccine's production process meets EU GMP standards and is suitable for halal certification, providing a competitive edge in Southeast Asian markets [10] Group 5: Long-term Value Creation - CanSino's vaccine matrix, including products for polio and DTP, is establishing a comprehensive defense against bacterial diseases in children, aligning with international quality standards [11] - The launch of PCV13i is expected to catalyze short-term performance while the ongoing innovation in the product matrix builds long-term value, suggesting potential for re-evaluation in market valuation [12]

Industry Overview - Vaccines are essential biological products for preventing and controlling infectious diseases, representing a core defense in public health systems [1][5] - The Chinese vaccine industry is experiencing rapid growth, with the market size projected to increase from 306.22 billion yuan in 2015 to 1,762.19 billion yuan in 2024, and expected to exceed 300 billion yuan by 2031 [1][5] Industry Chain - The upstream of the vaccine industry includes raw material supply, such as microcarriers, human serum albumin, and packaging materials [3] - The midstream involves vaccine research and production, with key players including Sinopharm, Sinovac, CanSino, Zhifei, and Watson [3] - The downstream consists of vaccine distribution and consumption, reaching end consumers through health service centers and medical institutions [3] Current Industry Status - As of December 31, 2024, 47 companies in China have received vaccine batch approvals, totaling 543 million doses, with a decrease of 5.6% compared to 2023 [7] - The most approved vaccines in 2024 were influenza and rabies vaccines, each exceeding 80 million doses, accounting for 30% of total approvals [9] Market Competition - The Chinese vaccine market is characterized by a diverse competitive landscape, with local companies like Sinopharm and Zhifei rising against foreign giants like Merck and Pfizer [11] - Zhifei has achieved significant growth in international markets, with a 300% increase in exports of its WHO-precertified 23-valent pneumococcal polysaccharide vaccine [11] - Innovative companies like CanSino and Watson are making breakthroughs in mRNA and recombinant protein vaccines, enhancing their market presence [11][12] Future Trends - Technological innovation is driving the vaccine industry forward, with new platforms like mRNA and gene-engineered vaccines emerging [17] - The adult vaccine market is growing, with a 45% increase in HPV vaccine uptake in 2024, indicating a shift in public health awareness [18] - Chinese vaccine companies are expanding internationally, with over 2.5 billion doses of COVID-19 vaccines supplied abroad, focusing on markets in Africa and Southeast Asia [19]

Macro Dynamics - In the first five months of 2025, China attracted foreign investment amounting to 358.19 billion RMB, a year-on-year decrease of 13.2% [1] - The number of newly established foreign-invested enterprises reached 24,018, marking a 10.4% increase year-on-year [1] - High-tech industries saw a significant increase in foreign investment, with e-commerce services up 146%, aerospace manufacturing up 74.9%, chemical pharmaceuticals up 59.2%, and medical equipment manufacturing up 20% [1] - Investment from ASEAN countries grew by 20.5%, while Japan, the UK, South Korea, and Germany saw increases of 70.2%, 60.9%, 10.3%, and 7.1% respectively [1] Financial Data - From January to May, the total stamp duty on securities transactions reached 66.8 billion RMB, a 52.4% increase year-on-year [2] - The overall stamp duty collected during the same period was 178.7 billion RMB, reflecting an 18.8% year-on-year growth [2] Industry Policies - The "old-for-new" subsidy policy for consumer goods will continue, with central funds being allocated in batches throughout the year [3] - A total of 300 billion RMB in national bond funds will be directed to support local governments in implementing the "old-for-new" policy [3] Energy Consumption - In May, China's total electricity consumption reached 809.6 billion kWh, a year-on-year increase of 4.4% [5] - Cumulative electricity consumption from January to May was 39,665 billion kWh, reflecting a 3.4% year-on-year growth [5] Company Dynamics - Ele.me's logistics head has been investigated for alleged job-related crimes, with the company cooperating with law enforcement [11] - Huizhou Yuantong was fined 24.31 million RMB by the People's Bank of China for multiple regulatory violations [13] - CanSino Biologics received a drug registration certificate for its 13-valent pneumococcal polysaccharide conjugate vaccine [14] - Zhang Xiaoqin's controlling shareholder has entered restructuring proceedings as approved by the local court [15] - Douyin has initiated a special action to combat corporate defamation and protect the rights of businesses and entrepreneurs [16] - Hainan Huatie clarified that it is not involved in stablecoin business and has no formal agreements with Ant Group regarding RWA [18]